chesapeake irb: risk and harm in research
TRANSCRIPT
Risk and Harm in Research
Chesapeake IRB
Copyright 2015 Chesapeake IRB
Assessment of Risks and Benefits
• An opportunity and a responsibility
For the researcher: a means to examine whether research is properly designed
For the IRB: a method for determining whether risks to subjects are justified
For the prospective subjects: assistance in determining whether or not to participate
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Important Concepts
• Risk: refers to the probability that some type of harm will occur
• Harm: refers to some outcome or event that has a level of magnitude (e.g., mere inconvenience, serious illness)
• Benefit: refers to something of positive value related to health or welfare
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Risk <≠> Benefits
Proper Contrasts :
Harms ó Benefits Risk of harms ó Probability of benefits
Magnitude of harms ó Magnitude of benefits
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Types of Benefits
• Gain to society or science through contribution to the knowledge base
• Gain to the individual – Through improved well-being, or – Through empowerment of the individual by giving
him/her a voice
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Types of Harm
• Mere inconvenience • Emotional harm: distress, embarrassment, trauma • Physical harm: from a research procedure or from
from those who would harm the subject for participating
• Social harm: disclosure leads to stigma, rejection of subject, persecution, loss of social status
• Economic Harm: Economic costs due to efforts to avoid or recover from other harms, loss of employment
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Sources of Harm
• Participation in research: reaction to materials or procedures; mere contact
• Breach of Confidentiality: Disclosure of information from subjects’ participation in research
• Socioeconomic: The impact of the research project after its completion
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“Minimal Risk”
• The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
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The “Daily Life” Standard
• Routine physical or psychological tests – Some discomfort or stress – Low magnitude – Transient, short duration
• Daily life encounters – Hassles, arguments, minor accidents that happen to
most people over a couple of years
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Interpreting “Risk”
• “Low-risk” refers to research where the worst harm possible is low-magnitude and transient, whether or not it is likely to occur
• “Minimal risk” refers to research where the worst harm likely is not very serious, and if it is, the probability of a subject experiencing it is extremely low
• “Greater than minimal risk” is all other research
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Minimizing Risk
• Alternatives – Substitute other procedures that are less risky
• Precautions – Incorporate procedures to decrease the likelihood that
harms will occur • Safeguards
– Incorporate procedures to deal with harms if they do occur
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Copyright 2015 Chesapeake IRB